FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes
FDA issued a warning letter to Leading Edge Health Inc. after reviewing the company’s website and determining that two sexual health products were being marketed as unapproved new drugs.
The products identified were “Erectin Stimulating Gel” and “VigRX Delay Wipes.” FDA cited website claims such as “INSTANT ERECTION formula,” “Rock Hard Erections,” and “Longer-Lasting Erections” as evidence that the products were intended to affect the structure or function of the body.
FDA also cited claims for VigRX Delay Wipes related to premature ejaculation, including references to numbing effects and blood circulation.
Because the products were marketed with drug-like claims but did not have FDA-approved applications, FDA concluded they were unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.
The warning letter directed the firm to respond within 15 business days with corrective actions and measures to prevent recurrence.
MDP Perspective
This warning letter is a useful reminder that product classification is driven by intended use, not by how a company wishes to position a product. Website language, product names, promotional claims, and implied benefits can all create drug status.
For companies marketing sexual health, wellness, or performance products, aggressive claims can quickly move a product from cosmetic or supplement positioning into drug territory. Once that happens, FDA expects an approved drug application or a clear legal marketing pathway.
Links
Warning letter to Leading Edge Health, Inc.
Warning Letter to Wild Arabic Herbs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales
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